Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
Global Core Electronic Medicinal Product Information (ePI), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions
{
"resourceType" : "Bundle",
"id" : "bundle-epi-type1-example-paracetamol",
"meta" : {
"versionId" : "1.0",
"lastUpdated" : "2024-03-20T10:00:00Z",
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/bundle-epi-type1"
]
},
"language" : "en",
"identifier" : {
"system" : "http://example.org/identifier",
"value" : "epi-paracetamol-t1"
},
"type" : "document",
"timestamp" : "2024-03-20T10:00:00Z",
"entry" : [
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/Composition/composition-paracetamol-t1",
"resource" : {
"resourceType" : "Composition",
"id" : "composition-paracetamol-t1",
"meta" : {
"versionId" : "1",
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"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><a name=\"Composition_composition-paracetamol-t1\"> </a><p>Package Leaflet: Information for the user - Paracetamol 500 mg tablets</p></div>"
},
"contained" : [
{
"resourceType" : "Binary",
"id" : "binaryImage-t1",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/binary-epi"
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"contentType" : "image/png",
"data" : "iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAQAAAC1HAwCAAAAC0lEQVR42mNkYAAAAAYAAjCB0C8AAAAASUVORK5CYII="
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"identifier" : [
{
"system" : "http://example.org/identifier",
"value" : "composition-paracetamol-t1"
}
],
"version" : "1.0",
"status" : "final",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi/",
"code" : "100000155538",
"display" : "Package Leaflet"
}
]
},
"subject" : [
{
"display" : "Paracetamol"
}
],
"date" : "2024-03-20T10:00:00Z",
"author" : [
{
"display" : "Acme Pharma Inc."
}
],
"title" : "Package Leaflet: Information for the user - Paracetamol 500 mg tablets",
"section" : [
{
"id" : "root-section",
"title" : "Package Leaflet",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi/",
"code" : "100000155538",
"display" : "Package Leaflet"
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]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\">Package Leaflet</div>"
},
"section" : [
{
"id" : "section-1",
"title" : "1. What Paracetamol 500 mg tablets is and what it is used for",
"code" : {
"coding" : [
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"system" : "https://spor.ema.europa.eu/rmswi/",
"code" : "100000155538",
"display" : "1. What Paracetamol 500 mg tablets is and what it is used for"
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]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><h3>1. What Paracetamol 500 mg tablets is and what it is used for</h3><p>Paracetamol belongs to a group of medicines called analgesics (painkillers) and antipyretics (medicines to reduce fever).</p><p>Paracetamol is used to relieve mild to moderate pain and fever.</p></div>"
}
},
{
"id" : "section-2",
"title" : "2. What you need to know before you take Paracetamol 500 mg tablets",
"code" : {
"coding" : [
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"code" : "100000155538",
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]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><h3>2. What you need to know before you take Paracetamol 500 mg tablets</h3><p><strong>Do not take Paracetamol:</strong> if you are allergic to paracetamol or any of the other ingredients of this medicine.</p><p><strong>Warnings and precautions:</strong> Talk to your doctor or pharmacist before taking Paracetamol if you have liver or kidney problems.</p></div>"
}
},
{
"id" : "section-3",
"title" : "3. How to take Paracetamol 500 mg tablets",
"code" : {
"coding" : [
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"system" : "https://spor.ema.europa.eu/rmswi/",
"code" : "100000155538",
"display" : "3. How to take Paracetamol 500 mg tablets"
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},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><h3>3. How to take Paracetamol 500 mg tablets</h3><p>Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.</p><p>The recommended dose is 1 tablet every 4 to 6 hours as needed. Do not take more than 6 tablets in any 24-hour period.</p></div>"
}
},
{
"id" : "section-4",
"title" : "4. Possible side effects",
"code" : {
"coding" : [
{
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"code" : "100000155538",
"display" : "4. Possible side effects"
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"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><h3>4. Possible side effects</h3><p>Like all medicines, this medicine can cause side effects, although not everybody gets them.</p><p>Stop taking the medicine and tell your doctor immediately if you experience allergic reactions such as skin rash or swelling.</p></div>"
}
},
{
"id" : "section-5",
"title" : "5. How to store Paracetamol 500 mg tablets",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi/",
"code" : "100000155538",
"display" : "5. How to store Paracetamol 500 mg tablets"
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},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><h3>5. How to store Paracetamol 500 mg tablets</h3><p>Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton.</p><p>This medicine does not require any special storage conditions.</p></div>"
}
},
{
"id" : "section-6",
"title" : "6. Contents of the pack and other information",
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"code" : "100000155538",
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"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><h3>6. Contents of the pack and other information</h3><p><strong>What Paracetamol contains:</strong> The active substance is paracetamol. The other ingredients are pregelatinized starch, povidone, stearic acid, talc, magnesium stearate, and hypromellose.</p><p><strong>What Paracetamol looks like and contents of the pack:</strong> Paracetamol tablets are white and round. They are available in blister packs of 30 or 50 tablets.</p></div>"
}
}
]
}
]
}
}
]
}
IG © 2022+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.emedicinal-product-info#1.1.0 based on FHIR 5.0.0.
Generated
2026-04-03
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